College of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea University, Sejong, South Korea.
College of Pharmacy, Korea University, Sejong, South Korea.
Sci Rep. 2023 Oct 17;13(1):17607. doi: 10.1038/s41598-023-44973-z.
Asthma is a chronic inflammatory condition that affects the lung airways. Chronic use of oral glucocorticoids in patients with severe asthma is associated with several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, reslizumab, and dupilumab) have been developed as alternative therapies for the treatment of asthma. In this study, we aimed to evaluate the risk of anaphylactic reactions associated with these five biologics based on a large global database. We utilized individual case reports from the Uppsala Monitoring Center from January 1968 to December 29, 2019. A disproportionality analysis was performed over all drugs and monoclonal antibodies. Anaphylactic reactions were defined according to the "anaphylactic reaction" of the standardized MedDRA queries. Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated positive signals related to anaphylactic reactions over all drugs and monoclonal antibodies. Reslizumab, which represented only 315 cases of all AEs, requires more reports to determine its association with anaphylactic reactions. More anaphylactic reactions have been identified than are known, and most cases (96.2%) are reported to be serious. Our findings indicate that omalizumab, benralizumab, and mepolizumab for asthma treatment are associated with a high risk of anaphylactic reactions; thus, more careful monitoring in the post-administration period is recommended.
哮喘是一种影响肺部气道的慢性炎症性疾病。慢性使用口服糖皮质激素治疗重症哮喘与多种不良事件（AE）相关。生物制剂（奥马珠单抗、贝那利珠单抗、美泊利珠单抗、瑞利珠单抗和度匹鲁单抗）已被开发为哮喘治疗的替代疗法。在这项研究中，我们旨在根据一个大型全球数据库评估这五种生物制剂相关的过敏反应风险。我们使用了 Uppsala 监测中心从 1968 年 1 月 1 日至 2019 年 12 月 29 日的个体病例报告。对所有药物和单克隆抗体进行了比例失调分析。过敏反应根据标准化 MedDRA 查询的“过敏反应”定义。与度匹鲁单抗相反，奥马珠单抗、贝那利珠单抗和美泊利珠单抗在所有药物和单克隆抗体中显示出与过敏反应相关的阳性信号。Reslizumab 仅占所有 AE 的 315 例，需要更多报告来确定其与过敏反应的关联。已经发现比已知的更多的过敏反应，大多数（96.2%）病例报告为严重。我们的研究结果表明，用于治疗哮喘的奥马珠单抗、贝那利珠单抗和美泊利珠单抗与过敏反应的高风险相关；因此，建议在给药后进行更仔细的监测。
